Yes, it's true. Gateway Analytical has one of the fastest turnaround times in the industry.

Better results. Faster. As soon as your sample comes through the door, we spring into action to properly log it, store it, and notify the individual scientists that will be diligently working on your project. Then it's off to specialized sample preparation and analytical probing by our fleet of cutting edge instruments. You'll have data, interpretation, and solutions in no time.

Gateway Analytical has carefully assembled a diverse team of curious experts. When the other guys run away from difficult problems or second guess their approach, our scientists move in to take a closer look with a forensic-based framework. Our process is focused on outcomes and driven by experts that have seen it all. You bring challenges. We deliver creative solutions.

We're not just another analytical lab. Why not? We spent years building a leading position in the highly-regulated pharmaceutical industry. That means our facilities are FDA-inspected, cGMP certified, and maintain ISO 9001 (quality management) and ISO 17025 (testing and calibration) standards. Simply put, there's a high bar for quality in all our work that others just can't match.

We've ditched one-size-fits-all customer service for a more personal, collaborative approach.

When you need us, call us. We're always here to answer your questions. As our growing list of returning customers has learned, you'll get to know the individual scientists working with your team to deliver results. They're real people. Our innovative real-time collaboration technology even allows us to demonstrate results and provide updates -- live from the lab.

Pharmaceutical Analysis Services From Gateway Analytical

Our FDA-inspected labs help to ensure our results are reproducible and our analyses are accurate. We have experience with every step of a drug product's market journey, with the ability to answer questions about drug development, transportation and handling, and manufacturing inconsistencies.

The size of the particles present within a drug product, including both the active pharmaceutical ingredient (API) and excipients, can significantly affect bioavailability and efficacy. Therefore, it is important to understand particle size distribution of ingredients to fully assess a pharmaceutical product and influence formulation development. This is especially true for generic drug developers, where bioequivalence studies can expedite marketing approval decisions from the FDA.

Gateway Analytical provides particle size distribution testing that allows our customers to obtain ingredient specific size information for nasal sprays, inhalable drugs administered through metered dose inhalers (MDI) and dry powder inhalers (DPI), creams, gels, ointments, and more. The information provided can be used to compare expected uptake, mode of action, and effect between two drug preparations, such as an innovator formulation and a generic challenger.

Our experts perform this service in two phases: Feasibility and Full Testing. During Feasibility, we assess the ability to distinguish specific ingredients. This is determined using Raman spectroscopy (RCI, SPE-Raman, or manual confocal Raman) to build a spectra reference library of the pure components comprising the drug product. Once established, we conduct Full Testing to determine ingredient specific particle size distribution, conduct statistical analyses, and collect representative particle images and spectra.

These types of analyses are crucial during the development of generics, proving bioequivalence, and in reverse-engineering of innovator drugs. Contact us today and learn how we can work together on your next project.

Related Analytical Instrumentation & Techniques

Our expert scientists conduct various analytical techniques using cutting-edge spectroscopy instruments. We take a forensic approach to problem solving that ensures we see through complexity to arrive at timely and accurate solutions focused on outcomes for your team.

This analysis produces high magnification images with excellent resolution, and contrast based on chemical makeup. Additionally, EDS indicates which elements are present in the sample. The SEM is a microscope that focuses a beam of electrons onto a sample, causing the sample to emit three types of signals. The instrument has detectors that process the signals that are emitted from the sample: Backscatter electrons, Secondary electrons, and X-Rays. Gateway uses the SEM systems for:

Manual SEM-EDS analysis for imaging/elemental information

High resolution imaging

AFA (Automated Feature Analysis)/automated SEM-EDS/CCSEM

CleanCHK

Single Particle Explorer (SPE)

The Single Particle Explorer quickly determines the size, shape, count and chemical composition of large populations of particles. The system analyzes particles down to 2 microns in size. The system combines imaging and spectroscopy (Raman and/or LIBS – Laser Induced Breakdown Spectroscopy) to provide detailed and efficient particle characterization.

Raman Chemical Imaging (RCI)

Gateway Analytical uses a Falcon II to perform Raman Chemical Imaging. Chemical Imaging combines optical spectroscopy, microscopy and digital imaging to provide image contrast based on chemical structure and concentration. This methodology combines the power of visual perception with the objectivity of spectroscopy to make characterization intuitive. In addition to basic chemical imaging, we perform ISPS (Ingredient Specific Particle Sizing), agglomerate identification, and polymorph studies.